Fentanyl Citrate Injection
FDA Recall NDC 0641-6249
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fentanyl Citrate (NDC 0641-6249). A significant event, classified as Class III, was initiated on May 13, 2015 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548)."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2015 Class III Recall: Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
May 13, 2015
Jun 24, 2015
14,649 Cartons
Recall Profile & Regulatory Data
Event ID
71378
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 06, 2016
Product Description
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Batch or Lot Expiration Information
Lot# : 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
Affected Packages Involved in this Recall
0641-6024-01Product
0641-6024-10Product
0641-6027-01Product
0641-6027-25Product
0641-6025-01Product
0641-6025-10Product
0641-6028-01Product
0641-6028-10Product
0641-6028-25Product
0641-6026-01Product
0641-6026-05Product
0641-6029-01Product
0641-6029-25Product
0641-6030-01Product
0641-6247-01Product
0641-6247-25Product
0641-6248-01Product
0641-6248-10Product
0641-6249-01Product
0641-6249-10Product
February 2015 Class III Recall: Failed Impurities/Degradation Specifications; 12 month stability testing.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; 12 month stability testing.
Feb 16, 2015
Apr 01, 2015
445,475 Vials
Recall Profile & Regulatory Data
Event ID
70548
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceutical Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 26, 2016
Product Description
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Batch or Lot Expiration Information
Lot# : 113312, Exp 11/2015; 014315 Exp 01/2016
Affected Packages Involved in this Recall
0641-6024-01Product
0641-6024-10Product
0641-6027-01Product
0641-6027-25Product
0641-6025-01Product
0641-6025-10Product
0641-6028-01Product
0641-6028-10Product
0641-6028-25Product
0641-6026-01Product
0641-6026-05Product
0641-6029-01Product
0641-6029-25Product
0641-6030-01Product
0641-6247-01Product
0641-6247-25Product
0641-6248-01Product
0641-6248-10Product
0641-6249-01Product
0641-6249-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
